Nuclear medicine is a branch of medicine that uses radioactive materials (e.g., radioisotopes) for various research, diagnostic and therapeutic applications. Radiopharmacies produce various radiopharmaceuticals (i.e., radioactive pharmaceuticals) by combining one or more radioactive materials with other materials to adapt the radioactive materials for use in a particular medical procedure.
For example, radioisotope generators may be used to obtain a solution comprising a daughter radioisotope (e.g., Technetium-99m) from a parent radioisotope (e.g., Molybdenum-99) which produces the daughter radioisotope by radioactive decay. A radioisotope generator may include a column containing the parent radioisotope adsorbed on a carrier medium. The carrier medium (e.g., alumina) has a relatively higher affinity for the parent radioisotope than the daughter radioisotope. As the parent radioisotope decays, a quantity of the desired daughter radioisotope is produced. To obtain the desired daughter radioisotope, a suitable eluant (e.g., a sterile saline solution) can be passed through the column to elute the daughter radioisotope from the carrier. The resulting eluate contains the daughter radioisotope (e.g., in the form of a dissolved salt), which makes the eluate a useful material for preparation of radiopharmaceuticals. For example, the eluate may be used as the source of a radioisotope in a solution adapted for intravenous administration to a patient for any of a variety of diagnostic and/or therapeutic procedures.
In one method of obtaining a quantity of eluate from a generator, an evacuated container (e.g., an elution vial) may be connected to the generator at a tapping point. For example, a hollow needle on the generator can be used to pierce a septum of an evacuated container to establish fluid communication between the container and the generator column. The partial vacuum of the container can draw eluant from an eluant reservoir through the column and into the vial, thereby eluting the daughter radioisotope from the column. The container may be contained in an elution shield, which is a radiation-shielding device used to shield workers (e.g., radiopharmacists) from radiation emitted by the eluate after it is loaded in the container.
After the elution is complete, the eluate may be analyzed. For example, the activity of the eluate may be calibrated by transferring the container to a calibration system. Calibration may involve removing the container from the shielding assembly and placing it in the calibration system to measure the amount of radioactivity emitted by the eluate. A breakthrough test may be performed to confirm that the amount of the parent radioisotope in the eluate does not exceed acceptable tolerance levels. The breakthrough test may involve transfer of the container to a thin shielding cup (e.g., a cup that effectively shields radiation emitted by the daughter isotope but not higher-energy radiation emitted by the parent isotope) and measurement of the amount of radiation that penetrates the shielding of the cup.
After the calibration and breakthrough tests, the container may be transferred to a dispensing shield. The dispensing shield shields workers from radiation emitted by the eluate in the container while the eluate is transferred from the container into one or more other containers (e.g., syringes) that may be used to prepare, transport, and/or administer the radiopharmaceuticals. Typically, the dispensing process involves serial transfer of eluate to many different containers (e.g., off and on throughout the course of a day). The practice of using a different shielding device for dispensing than was used for elution stems from the fact that it is common industry practice to place the shielded container upside down on a work surface (e.g., tabletop surface) during the idle periods between dispensing of eluate to one container and the next. Prior art elution shields are generally not conducive for use as dispensing shields because, among other reasons, they may be unstable when inverted. For example, some elution shields have a heavy base that results in a relatively high center of gravity when the elution shield is upside down. Further, some elution shields have upper surfaces that are not adapted for resting on a flat work surface (e.g., upper surfaces with bumps that would make the elution shield unstable if it were placed upside down on a flat surface). Radiopharmacies have addressed this problem by maintaining a supply of elution shields and another supply of dispensing shields.
The same generator may be used to fill a number of elution containers before the radioisotopes in the column are spent. The volume of eluate needed at any time may vary depending on the number of prescriptions that need to be filled by the radiopharmacy and/or the remaining concentration of radioisotopes in the generator column. One way to vary the amount of eluate drawn from the column is to vary the volume of the evacuated container used to receive the eluate. For example, container volumes ranging from about 5 mL to about 30 mL are common and standard containers having volumes of 5 mL, 10 mL, or 20 mL are currently used in the industry. A container having a desired volume may be selected to facilitate dispensing of a corresponding amount of eluate from the generator column.
Unfortunately, the use of multiple different sizes of containers is associated with significant disadvantages. For example, a radiopharmacy may attempt to manipulate a conventional shielding device so that can be used with containers of various sizes. One solution that has been practiced is to keep a variety of different spacers on hand that may be inserted into shielding devices to temporarily occupy extra space in the radiation shielding devices when smaller containers are being used. Unfortunately, this adds complexity and increases the risk of confusion because the spacers can get mixed up, lost, broken, or used with the wrong container and may be considered inconvenient for use. For instance, some conventional spacers surround the sides of the containers in the shielding-devices, which is where labels may be attached to the containers. Accordingly, the spacers may mar the labels and/or contact adhesives used to attach the labels to the container resultantly causing the spacers to stick to the sides of the container or otherwise gum up the radiation-shielding device.
Another problem with conventional radiation-shielding systems is that dispensing shields may be somewhat inconvenient to handle. Whereas elution shields may be handled between one and ten times in a typical day, which limits the importance of the ergonomics of elution shields, a dispensing shield may be handled hundreds of times in a typical day. This makes the ergonomics of dispensing shields important. Prior art dispensing shields can be relatively heavy (e.g., 3-5 pounds) and have utilitarian designs focusing on radiation-shielding and function rather than ease of handling. For example, dispensing shields can be cylindrical, have sharp edges, and lack an obvious place for gripping them. Because of the repetitive handling of dispensing shields by workers, the aggregate toll of the foregoing inconveniences can add up to discomfort, injury, and other problems.
Further, each time a worker lifts a dispensing shield to transfer eluate from the container housed therein to other containers, the worker is exposed to radiation escaping the dispensing shield through the opening that is used to access the container. A worker can significantly reduce exposure to radiation in the dispensing process by gripping the dispensing shield at a place that is relatively farther from the opening rather than a place that is relatively closer to the opening. Unfortunately, prior art dispensing shields do little to discourage the practice of gripping the dispensing shield near the opening, putting the onus on the individual worker to be mindful of hand placement when handling a dispensing shield.
Thus, there is a need for improved radiation-shielding systems and methods of handling containers containing one or more radioisotopes that facilitate safer, more convenient, and/or more reliable handling of radioactive materials.